PROMETHEGAN

{
  "unii": {
    "unii": "R61ZEH7I1I",
    "rxcui": "142445",
    "inchikey": "XXPDBLUZJRXNNZ-UHFFFAOYSA-N",
    "display_name": "PROMETHAZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RECTAL",
  "spl_meta": {
    "6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97": {
      "match": "brand_token",
      "title": "PROMETHEGAN (PROMETHAZINE HYDROCHLORIDE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "14",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0713-0132_0b625ebc-4f41-49d9-e063-6294a90a56ef",
  "productndc": "0713-0132",
  "dosage_form": "SUPPOSITORY",
  "orange_book": {
    "appl_no": "087165",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Aug 14, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PROMETHAZINE HYDROCHLORIDE",
  "shortage_reason": "Promethazine Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "PROMETHEGAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA087165",
  "marketing_category": "ANDA",
  "nonproprietary_name": "promethazine hydrochloride",
  "start_marketing_date": "19870831",
  "active_numerator_strength": "50"
}